Autoimmune diseases are characterized by a reaction of the immune system against its own organism. These reactions may, for example, be caused by the recognition of auto-antigens by the T lymphocytes, which trigger humoral (auto-antibodies production) and cellular (increased lymphocytes and macrophages cytotoxic activity) immune responses. Autoimmune diseases include: rheumatoid diseases, psoriasis, systemic dermatomyocytis, multiple sclerosis, lupus erythematosus, and exaggerated immune responses to antigens, i.e., asthma, allergies to drugs and food, etc. All these diseases are limiting, chronic, and in some cases lethal, and no effective therapy exists nowadays to treat them. Therefore, any drug, medicine, or media that is able to cause remission or decrease in the course of the disease, represents a significant solution for the patients health.
The search for a treatment for autoimmune diseases has resulted in an important effort to find suitable drugs and methods.
At present, the treatment of these diseases is principally based in the use of immunosuppressant drugs, such as glucocorticoids, calcineurin inhibitors, anti-proliferatives and anti-metabolites. However, since these pharmacological therapies act on many different targets, they can reduce the immune function as a whole, or due to long term use, can have the disadvantage of different cytotoxic effects and may therefore can suppress the immune system in a non specific way, exposing the patient to the risk of infections and cancer. Calcineurin and glucocorticoids exhibit an additional disadvantage, due to their nephrotoxicity and diabetogenic effects, that limits their utility in several clinical conditions (e.g., renal insufficiency, diabetes).
The latest therapeutic advances in immuno-suppression are the anti-CD3 monoclonal antibodies, the anti IL-2 receptor monoclonal antibodies, and the anti-TNF-alpha monoclonal antibodies. Despite the fact that these treatments exhibit marked immunosuppressing effects, anaphylaxis reactions, opportunistic infections (e.g., tuberculosis) and neoplasms, fever, urticaria, hypotension and dyspnea are associated with these medicines, representing a serious problem in the application of said compositions and pharmaceutical products. In injectable applications, one out of three patients can experience itching, swelling and pain.